WO2019028010A1 - Système de drainage avec bague de retenue - Google Patents

Système de drainage avec bague de retenue Download PDF

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Publication number
WO2019028010A1
WO2019028010A1 PCT/US2018/044582 US2018044582W WO2019028010A1 WO 2019028010 A1 WO2019028010 A1 WO 2019028010A1 US 2018044582 W US2018044582 W US 2018044582W WO 2019028010 A1 WO2019028010 A1 WO 2019028010A1
Authority
WO
WIPO (PCT)
Prior art keywords
retention ring
collar
cap
mouth
tab
Prior art date
Application number
PCT/US2018/044582
Other languages
English (en)
Inventor
James C. KANTOLA
Shayna Massi
John A. Krueger
Daniel A. GORSKY
Robert Gerald STATES
Original Assignee
Becton, Dickinson And Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton, Dickinson And Company filed Critical Becton, Dickinson And Company
Priority to CA3071622A priority Critical patent/CA3071622A1/fr
Priority to EP18756077.6A priority patent/EP3661572A1/fr
Publication of WO2019028010A1 publication Critical patent/WO2019028010A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/64—Containers with integrated suction means
    • A61M1/66—Pre-evacuated rigid containers, e.g. Redon bottles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/60—Containers for suction drainage, adapted to be used with an external suction source
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/73—Suction drainage systems comprising sensors or indicators for physical values
    • A61M1/732—Visual indicating means for vacuum pressure

Definitions

  • the present invention relates to the field of medical devices and, in particular, to a device useful for withdrawing and containing fluids from a patient body.
  • Body fluids may need to be withdrawn from a patient in the course of medical treatment.
  • Two common medical procedures requiring fluid removal are thoracentesis and paracentesis.
  • peritoneal fluid is aspirated from the abdomen.
  • Typical patients have tense ascites resulting from liver disease and portal hypertension, which may cause discomfort, respiratory distress, and the formation and rupture of umbilical hernias.
  • Paracentesis has been observed to provide quick and effective relief with few adverse side effects.
  • Other treatment options such as the use of diuretics, are available, but may not provide as effective relief as paracentesis.
  • many patients with ascites have renal impairment and cannot use the high doses of diuretics necessary to effectively treat the ascites.
  • a paracentesis device need only include a hollow needle with one end inserted into the patient and the other end attached to a negative pressure device, such as a syringe or vacuum bottle.
  • a negative pressure device such as a syringe or vacuum bottle.
  • more specialized devices have been developed to allow safer, more comfortable, and more sanitary paracentesis. These devices may allow for body fluid to be dispensed into at least two containers, so that one container may be filled with fluid for diagnostic purposes and the other container may be filled with waste fluid.
  • Another development has been the use of Kuss or Verres type needle assemblies, where a blunt drainage needle is attached to a retractile sharp introducer needle. This reduces the likelihood of the sharp needle damaging internal tissue during paracentesis.
  • a further development is to drain body fluid through a blunt-tipped catheter introduced by a sharp introducing needle, which allows the sharp needle to be removed from the patient after a relatively quick introduction process and avoids the prolonged presence of a sharp needle in the body of the patient.
  • Thoracentesis is a procedure similar to paracentesis, except that effusion fluid is withdrawn from the pleural region instead of the abdomen.
  • the pleural space contains approximately 5 to 20 ml of fluid.
  • the fluid is the result of the hydrostatic- oncotic pressure of the capillaries of the parietal pleura.
  • the turnover of the fluid in the pleural space is normally quite rapid, so that approximately 0.5 to 5 liters (e.g., 1 to 2 liters) of fluid move through the pleural space each day.
  • a disruption in the balance between the movement of fluid into the pleural space and the movement of fluid out of the pleural space may produce excessive fluid accumulation in the pleural space.
  • Pleural effusion is particularly common in patients with disseminated breast cancer, lung cancer or lymphatic cancer and patients with congestive heart failure, but also occurs in patients with many other forms of malignancy.
  • Pleural effusion may cause dyspnea, coughing, and chest pain, which diminish a patient's quality of life. Although pleural effusion typically occurs toward the end of terminal malignancies, such as breast cancer, it occurs earlier in other diseases.
  • Pleurectomy and pleural abrasion are generally effective in obliterating the pleural space, thus controlling the malignant pleural effusion.
  • pleurectomy is a major surgical procedure associated with substantial morbidity and some mortality.
  • Chemotherapy is generally disappointing; however, it may produce good responses for patients with lymphoma, breast cancer, or small-cell carcinoma.
  • Another approach is to surgically implant a chest tube.
  • a chest tube is painful to the patient, both when it is inserted and during the time that it remains in the pleural space. Improvements on the traditional chest tube are described in U.S. Pat. No. 5,484,401.
  • thoracentesis remains the most common approach to removing pleural fluid.
  • thoracentesis poses the danger of causing pneumothorax, a collapsed lung.
  • Pneumothorax can be caused directly by puncturing a lung with a needle assembly or catheter tip or indirectly by allowing air to enter the pleural space.
  • the pleural space is at negative pressure relative to the atmosphere, which helps keep the lungs expanded. If the atmosphere is allowed to communicate with the pleural space, the pleural space may no longer be at negative pressure and pneumothorax may result.
  • Thoracentesis devices have been developed to reduce the risk of pneumothorax and other similar problems that may result from the procedure. In general, these devices incorporate similar protections as do paracentesis devices. For example,
  • U.S. Pat. No. 4,447,235 by Clarke discloses a thoracentesis device with a catheter introduced by a removable needle assembly, with a valve that closes upon removal of the needle assembly. The purpose of the valve is to prevent air from entering the body of the patient.
  • U.S. Pat. Nos. 4,784,156, 4,832,044, 4,840,184, and 4,844,087 by Garg disclose similar devices with a manual valve that may be closed after withdrawal of the needle assembly.
  • none of the previous devices allow for a truly fail-safe operation, as various valves must be properly set by the operator when changing from one drain port to another or when withdrawing the introducing needle assembly from the patient.
  • a Verres-type needle assembly that may be used for thoracentesis is disclosed in U.S. Pat. No. 5,334,159 by Turkel. While this reduces the risk of pneumothorax due to lung puncture, the Turkel device does not improve the safety of thoracentesis when the introducing needle assembly is withdrawn or solve the problems associated with multiple drainage ports. Thus there is a need for a safer and more reliable device that may be used for paracentesis and thoracentesis. Another device is described in U.S. Pat. No. 5,725,506 by Freeman, et al., which is incorporated by reference herein in its entirety.
  • a bottle with a perfect vacuum inside looks no different than a bottle of air, but the drainage efficacy of the unit may be diminished upon loss of vacuum before use or during use where the vacuum is wasted on pulling in air rather than exerting drainage effectively from the patient.
  • Another problem is in tapping the bottle. This requires a system that pierces a vacuum seal but does not allow air to enter the bottle, except through the draw line.
  • a cap may be provided that acts as an interface between the bottle and a drainage line.
  • an adhesive such as a silicone adhesive gel.
  • the silicone gel may act both to secure the cap to the bottle and to create a fluid seal at the junction.
  • silicone gel adhesive typically is expensive and manufacturing expenses associated with applying a silicone gel remain high. Further, it can be difficult to apply a precise amount of adhesive during the assembly process to achieve consistent securing and sealing that will patently maintain desired vacuum throughout the device live and usage. Silicone adhesives also typically can only dry and set one time, shortly after application, and therefore the system is generally shipped fully assembled, and it may be difficult to interchange the vacuum bottles at the medical facility. Further, the use of an suitable amount of adhesive to form an adequate seal may secure the cap the bottle to a degree such that is difficult to remove by a user, thus making it difficult for user the to remove the cap prior to disposing medical waste collected within the bottle.
  • the present disclosure provides a drainage system.
  • the drainage system may include a container having an interior and a mouth, the mouth having an outer surface and an opening.
  • a frangible seal may cover the opening.
  • a cap may be secured to the mouth, and the cap may be in fluid communication with a drainage line.
  • the cap may have an inner surface for engaging with the outer surface of the mouth.
  • the drainage system may further include a retention ring with a collar having an inner surface configured to engage an outer surface of the cap, where the retention ring includes a bead for at least partially concentrating a restriction force provided by the retention ring on an adjacent area of the outer surface of the cap.
  • the outer surface of the mouth includes a protrusion, where the bead of the retention ring is located distally of the protrusion of the mouth.
  • the retention ring may include a tab extending from the collar, the tab having a surface for receiving a removal force.
  • the collar of the retention ring may include a collar portion having a relatively low bending moment of inertia with respect to adjacent areas of the collar such that the collar portion deforms in response to the removal force being received by the tab.
  • the surface of the tab of the retention ring may face distally, and the tab of the retention ring may include a rib on its proximal side extending to a lip of the collar.
  • the retention ring may include a prong with a point for increasing the size of an opening of the frangible seal.
  • the drainage system may include a spike with a flange, the spike being configured to pierce the frangible seal in response to an initiation force being applied to the flange in a distal direction
  • the drainage system may further include a safety clip engaged with the cap and located at least partially between the flange of the spike and the retention ring.
  • the safety clip may include a groove for receiving at least a portion of the collar of the retention ring.
  • the present disclosure provides a retention ring for a drainage system.
  • the retention ring may include a collar having an inner surface forming a generally circular opening and a bead extending from the inner surface of the collar.
  • the bead may be configured for at least partially concentrating a restriction force on an adjacent area of an outer surface of a cap.
  • the retention ring may include a extending from the collar, where the tab has a surface for receiving a removal force.
  • the collar of the retention ring may include a collar portion having a relatively low bending moment of inertia with respect to adjacent areas of the collar such that the collar portion deforms in response to the removal force being received by the tab.
  • the surface of the tab of the retention ring may face distally, and the tab of the retention ring may include a rib on its proximal side extending to a lip of the collar.
  • the rib may include a gusset.
  • the retention ring may additionally or alternatively include a prong with a point for increasing the size of an opening of a frangible seal.
  • a 3-D printing process may be used to form the retention ring, and the retention ring may include at least one of a polypropylene material and a nylon material.
  • the present disclosure provides a method.
  • the method may include piercing a frangible seal with a spike where the frangible seal covers an opening of a mouth of a container and exposing a drainage line to a vacuum initially contained in an interior of the container.
  • a cap may provide fluid communication between the interior of the container and the drainage line, where the cap is engaged with an outer surface of the mouth, where a seal is provided between the outer surface of the mouth and the cap by a compression force, where the compression force is provided by a collar of a retention ring, the collar including an inner surface positioned in engagement with an outer surface of the cap, and where the inner surface of the collar includes a bead for at least partially concentrating the compression force on an area of the cap adjacent to the bead.
  • the outer surface of the mouth may include a protrusion, where the bead of the retention ring is located distally of the protrusion of the mouth.
  • the method may further include removing the retention ring from engagement with the cap by applying a removal force to a tab of the retention ring, where the tab of the retention ring is coupled to the collar of the retention ring, and where a collar portion of the collar bends in response to the application of the removal force.
  • the method may additionally or alternatively include the step of increasing the size of an opening of the pierced frangible seal by manipulating a prong of the retention ring through the opening.
  • FIG. 1 is an illustration showing a front cut-out schematic of one embodiment of a drainage system with a retention ring in accordance with the present disclosure.
  • FIG. 2 is an illustration showing a side perspective view of a portion of the drainage system with a retention ring.
  • FIG. 3 is an illustration showing a side section view of a portion of the drainage system of FIG. 2 about line 3-3.
  • FIG. 4 is an illustration showing a magnified view of a portion of FIG. 3.
  • FIG. 5 is an illustration showing a side view of a portion of the drainage system to illustrate the relative non-deformed state of certain components.
  • FIG. 6 is an illustration similar to FIG. 5, but showing the components as they may appear as deformed when the retention ring is installed.
  • FIG. 7 is an illustration similar to FIG. 6, but showing the components as they may appear as deformed when the retention ring is installed and the interior of a cap of the drainage system is exposed to a vacuum.
  • FIG. 8 is an illustration showing a side section view of the retention ring depicted in FIGS. 2 about line 3-3, where the retention ring is deformed due to a force provided on a tab of the retention ring.
  • FIG. 9 is an illustration showing a perspective view of a tab of the retention ring of the drainage system.
  • FIG. 10 is an illustration showing a side view of the retention ring of the drainage system.
  • FIG. 1 1 is an illustration showing another side perspective view of the retention ring as a prong of the retention ring opens a frangible seal coupled to a mouth of a container.
  • FIGS. 12A-D are illustrations showing a side perspective view of the drainage system incorporating a safety clip.
  • proximal and distal are used herein in the common usage sense where they refer respectively to a handle/doctor-end of a device or related object and a tool/patient-end of a device or related object.
  • the terms “about,” “substantially,” “generally,” and other terms of degree, when used with reference to any volume, dimension, proportion, or other quantitative or qualitative value, are intended to communicate a definite and identifiable value within the standard parameters that would be understood by one of skill in the art (equivalent to a medical device engineer with experience in this field), and should be interpreted to include at least any legal equivalents, minor but functionally-insignificant variants, standard manufacturing tolerances, and including at least mathematically significant figures (although not required to be as broad as the largest range thereof).
  • FIG. 1 is an illustration showing a front cut-out schematic of one embodiment of a drainage system 100.
  • the drainage system 100 may include a container 102, which may be a bottle or a vacuum bottle (or other suitable container).
  • the container 102 may have a mouth 104 with an outer surface 106 and an opening 108 at its proximal end 1 10.
  • the opening 108 may lead to an interior 1 12 of the
  • a cap 1 14 may cover the opening 108 of the mouth 104 and may lead to a drainage line 1 16.
  • the cap 1 14 may have a sleeve 1 18 at its upper (distal) end and a widened body 120 at its lower (proximal) end.
  • the sleeve 1 18 of the cap 1 14 may receive a spike 122 in a manner such that a substantially air-tight seal is formed between the exterior surface of spike 122 and a lumen 124 of sleeve 1 18.
  • the lower end of spike 122 may terminate at a point 134.
  • the upper end of spike 122 may receive the drainage line 1 16.
  • the connection between spike 122 and drainage line 1 16 is preferably substantially air-tight.
  • the spike 122 may also include a
  • circumferential flange 132 to assist in manipulating the spike 122 in relation to
  • a lumen 138 may extend through spike 122 such that a lumen 126 of the drainage line 1 16 can communicate with the container 102 during a drainage procedure.
  • a frangible seal 128 may cover the opening 108 of the mouth 104 prior to initiation of the drainage procedure. Prior to being pierced, the frangible seal 128 may seal the interior 1 12 of the container 102 from the external environment 130. More particularly, the frangible seal 128 may be constructed of foil, mylar, or other
  • the frangible seal 128 may be attached to the mouth 104 via heat- sealing (as in, for example, direct heat, induction heat or vibration generated heating processes), by gluing or using another adhesive, and/or by any other suitable method.
  • the drainage system 100 may be packaged and shipped as an assembly that includes the container 102 with the interior 1 12 sealed by the frangible seal 128.
  • the interior 1 12 of the container 102 is preferably pre-loaded with a vacuum (and herein, a "vacuum” may refer to an
  • vacuum does not necessarily require the space to be entirely devoid of matter). It is also contemplated that the vacuum may be loaded by the patient (e.g., by hooking the container 102 to a vacuum pump).
  • the distal end (not shown) of the drainage line 1 16 may be attached to a collection device that is at least partially placed into a target space in the body of a patient.
  • the collection device may include a catheter that can be placed in the pleural space of the patient to remove excess pleural fluid via a needle within the body of the patient.
  • This force may deform the cap 1 14, and particularly the widened body 120 of the cap 1 14 in the depicted embodiment, such that the spike 122 moves distally and such that the point 134 of the spike 122 pierces the frangible seal 128.
  • the vacuum loaded within the interior 1 12 of the container 102 may communicate with the drainage line 1 16 to draw fluid (including gasses and liquids) from the target space of the patient body and/or the collection device, through the drainage line 1 16, and ultimately into the interior 1 12 of the container 102.
  • the cap 1 14 In its default position (i.e., when not exposed to the vacuum), the cap 1 14 may appear substantially different than it may appear when exposed to the vacuum of the interior 1 12.
  • the widened body 120 of the cap 1 14 may at least partially collapse. This partial collapse will thus be apparent to the user and will verify the existence of the vacuum.
  • the state of the cap 1 14 may further indicate the state of the vacuum as the drainage procedure continues, and the cap 1 14 may indicate that the vacuum has been exhausted when it returns fully to its default state.
  • the cap 1 14 may be secured to the container 102 via a silicone adhesive, and/or an O-ring may be located between the cap 1 14 and the underlying mouth 104 of the container 102 to ensure a suitable seal.
  • a silicone adhesive and/or an O-ring may be located between the cap 1 14 and the underlying mouth 104 of the container 102 to ensure a suitable seal.
  • retention ring 140 (which may also be referred to as a retaining ring) may be included to facilitate securement of the cap 1 14 to the container 102.
  • the retention ring 140 may be formed integrally (e.g., by injection molding, 3D printing, or another suitable method), and may be formed of any suitable material.
  • the retention ring 140 may be formed of a polypropylene material or a nylon.
  • FIG. 2 is an illustration showing a side perspective view of a portion of the drainage system 100.
  • the retention ring 140 may have a collar 142 that circumferentially engages an outer surface 144 of the cap 1 14, thereby squeezing or otherwise providing a constricting force to retain the cap 1 14 in engagement with the mouth 104 of the container 102. This constriction provided by the retention ring 140 may compress the elastomeric material of the cap 1 14 against the mouth 104 of the
  • the retention ring 140 may be installed (i.e., manipulated into its position around the cap 1 14 and mouth 104 as shown in FIG. 2) by a user prior to a drainage procedure when attaching the cap 1 14 to the container 102, or the retention ring 140 may be installed prior to packaging and shipping of the drainage system 100.
  • FIG. 3 shows a side section view of a portion of the drainage system 100 of FIG. 2 about line 3-3
  • FIG. 4 shows a magnified view of a portion of FIG. 3.
  • the collar 142 of the retention ring 140 may circumferentially engage the cap 1 14.
  • the collar 142 of the retention ring 140 may be sized such that it provides a constriction force on the outer surface 144 of the cap 1 14 when the cap 1 14 is located over the mouth 104 of the container 102.
  • the retention ring 140 may include the collar 142 with an inner diameter that is slightly larger than an outer diameter defined by the outer surface 106 of the mouth 104.
  • the cap 1 14 may have a default thickness 148 (e.g., a thickness when not deformed by the retention ring 140).
  • the default thickness may be about 0.075 inches in at least some locations, but other suitable dimensions are also contemplated (e.g., the default thickness may be between about 0.010 inches and about 0.150 inches, such as between about 0.060 inches and about 0.080 inches). Adjacent to where the retention ring 140 engages the cap 1 14 during a drainage procedure, the cap 1 14 may be compressed such that the thickness at the area where the retention ring 140 engages the cap 1 14 is smaller than the cap's default thickness.
  • the retention ring 140 may include a bead 150 located on an inner surface 152 of the collar 142 of the retention ring 140, where the inner surface 152 defines the inner diameter of the collar 142. While only one bead 150 is shown in the present figure, more than one bead may be included.
  • the bead 150 may have an apex 153, which may be closer to an axis 154 through the center of the collar 142 of the retention ring 140 relative to adjacent areas of the inner surface 152. While any suitable dimensions are contemplated, the bead 150 may be an arc with a diameter of about 0.052 inches, and the apex 153 may be about 0.575 inches from the center of the collar 142 at its closest point.
  • the apex 153 of the bead 150 may be formed integrally with the remainder of the retention ring 140 (e.g., through a common injection molding process, 3D printing process, or other suitable process), or it may be installed after formation of the remainder of the retention ring 140.
  • the apex 153 may be advantageous for concentrating the above-described constriction force on a relatively small area of the cap 1 14 when the retention ring 140 is engaged with the cap 1 14 around the mouth 104 of the container 102, as shown in FIG. 4.
  • the resulting deformation of the relatively small area receiving a high proportion of the constricting force may provide an enhanced seal between the mouth 104 and the cap 1 14 with respect to other embodiments.
  • the constriction force may provide at least 50 psi of contact pressure between the cap 1 14 and the mouth 104 adjacent to the apex 153 around the entirety of the mouth 104, and the contact pressure may be significantly higher in certain locations.
  • the concentration of the contraction force may provide enhanced ability to retain the seal between the mouth 104 and the cap 1 14 over relatively long period of time (e.g., 2 years or more), which is advantageous for supply-chain efficiency due to the ability to store the system for a relatively long time period prior to use.
  • the mouth 104 of the container 102 may include a protrusion 156 around the outer diameter defined by the outer surface 106 of the mouth 104.
  • the protrusion 156 may have dimensions similar to the bead 150 with respect to the outer surface 106 of the mouth 104, but this is not required.
  • protrusion 156 may be located just proximal (above) the bead 150 of the retention ring 140 when the retention ring 140 is installed, but other locations are also
  • the protrusion 156 may be advantageous for concentrating compression at a relatively small area of the cap 1 14 to provide an enhanced seal. Additionally or alternatively, the protrusion 156 may retain the retention ring 140 in place by preventing distal-to-proximal movement of the retention ring 140 relative to the mouth 104 when the retention ring 140 is installed around the cap 1 14 and mouth 104. In some embodiments, the cap 1 14 may also (or alternatively) include a protrusion 156 and/or a channel for receiving the bead 150 to facilitate suitable positioning of the retention ring 140 with respect to the cap 1 14.
  • the protrusion 156 and/or the bead 150 may be rounded or otherwise shaped such that, when a force is applied to the retention ring 140 to install the retention ring 140 around the mouth 104 or remove the retention ring 140, at least one of the mouth 104 and the retention ring 140 slightly deforms to allow passage of the bead 150 beyond the protrusion.
  • the retention ring 140 may be more easily deformed than the mouth 104.
  • the protrusion 156 and/or the bead 150 may be positioned on their respective elements such that, when installed, the retention ring 140 is forced into a position such that it contacts a shoulder 158 of the container 102 and/or a lip 146 of the cap 1 14.
  • the retention ring 140 may be substantially fixed in place with respect to the mouth 104 and cap 1 14 when installed (absent a removal force).
  • FIGS. 5-7 are figures showing a portion of the drainage system 100 to further illustrate the respective fits of the cap 1 14 around the mouth 104 and the retention ring 140 around the cap 1 14.
  • FIG. 5 shows the cap 1 14 as it may appear relative to the mouth 104 and the retention ring 140 when the cap 1 14 is not deformed.
  • the protrusion 156 and the bead 150 may extend into the default path of the cap 1 14.
  • the cap 1 14 may be forced to deform when the cap 1 14 is installed around the mouth 104 and/or the retention ring 140 is installed around the cap 1 14 as shown in FIG. 6.
  • a bead gap which may be defined as the shortest distance between the protrusion 156 and the bead 150 in the horizontal direction of FIG. 6, may be
  • the dimensions and orientation of the protrusion 156, the bead 150, and the remainders of the mouth 104 and retention ring 140 may cause the material of the cap 1 14 to compress, thereby enhancing the seal.
  • the above-described bead gap may be smaller than the default thickness of the cap 1 14 (see FIG. 4).
  • the cap 1 14 may compress to about 20% to about 80% of its default thickness (e.g., about 50%) when the retention ring 140 is engaged.
  • FIG. 7 is similar to FIG. 5, but shows the above- described elements as they may appear when the interior of the cap 1 14 is exposed to the vacuum provided by the interior 1 12 of the container 102.
  • the cap 1 14 may be formed of a material that is relatively compliant or otherwise compressible.
  • the cap 1 14 may be substantially formed by MedipreneTM 500700M-02 supplied by HEXPOL TPE or SantopreneTM 8281-65MED supplied by ExxonMobile.
  • FIG. 8 is an illustration showing a side section view of the retention ring 140, where the retention ring is deformed due to a force provided on a tab 160 of the retention ring 140.
  • the tab 160 may be integrally formed (e.g., injection molded) with the remainder of the retention ring 140.
  • the tab 160 may include a surface 162 facing approximately distally, where the surface 162 is configured to receive a removal force provided by a user (e.g., through contact and pressure with a finger on the surface 162, for example).
  • the surface 162 may optionally include grip elements 163 for suitable friction/grip with a finger or hand of a user.
  • the tab 160 may include an extension 161 that is configured to abut the shoulder 158 of the container 102 when the retention ring 140 is installed.
  • the shoulder 158 may be spaced from the extension 161 unless a downward force is provided on the tab 160, thus engaging the extension 161 with the shoulder 158.
  • the extension 161 may transfer the force to the shoulder 158 to prevent the retention ring 140 from deforming to a degree such that it is inadvertently removed from its engaged state.
  • the retention ring 140 may deform. As described in more detail below (with reference to FIG. 8), a rim portion of the retention ring 140 may be more easily deformed than other portions of the retention ring 140 such that the retention ring 140 deforms in a particular manner such that it manipulates itself out of engagement with the mouth 104 when the removal force 164 is provided.
  • the retention ring 140 may include a lip 166 on the proximal side of the collar 142. In some embodiments, the lip 166 may taper outwards such that it is not snug with the mouth 104. In other embodiments, the lip 166 may be flush with the mouth 104.
  • the lip 166 may be configured to engage with a proximal end 1 10 of the mouth 104 (e.g., through the thickness of the cap 1 14) when the removal force 164 is applied such that the lip 166 pivot around the mouth 104 and presses into the cap 1 14.
  • the partial collapse of the cap 1 14 due to this pressure may enhance the ability of the retention ring 140 to remove the cap 1 14 and/or may reduce the minimum remove force 164 sufficient for cap removal.
  • the pivot of the lip 166 may additionally or alternatively cause the lip 166 to press distally against the proximal end 1 10 of the mouth 104 (e.g., through the compliant material of the cap 1 14), thereby facilitating proximal removal of the retention ring 140 from the mouth 104.
  • a lever-like effect of the lip 166 pressing against the mouth 104 and/or the outer surface 144 of the cap 1 14 may assist in deforming the retention ring 140 such that the bead 150 can pass the protrusion 156 of the mouth 104 of the container 102.
  • a removal force of between about 2 pounds and 16 pounds may be sufficient to remove the retention ring 140, such as about 7.8 pounds at nominal conditions. This force required for removal may vary depending on the specific dimensions of the cap 1 14, retention ring 140, and mouth 104, as well as the materials forming these elements and the friction coefficient between said elements.
  • the retention ring 140 may be designed such that different removal forces are adequate in other embodiments, and it is contemplated that the minimum force for removing the retention ring 140 may change as the drainage system ages.
  • tab 160 Only one tab 160 is depicted in FIG. 8, but more than one tab 160 may be included. For example, it may be advantageous to provide a tab 160 on opposite sides of the collar 142 of the retention ring 140 such that a user can provide removal forces on the respective opposite sides of the collar 142. It is further contemplated that the tab 160 may include a surface on its proximal side and related elements (e.g., elements to provide a lever-like effect) configured to receive an installation force by a user or other person when installing the retention ring 140 around the mouth 104 and/or cap 1 14.
  • elements e.g., elements to provide a lever-like effect
  • the proximal side of the tab 160 may optionally include structural ribs 170 and/or other structural features such that the tab 160 is relatively stiff (at least when compared to portions of the collar 142).
  • the ribs 170 may in particular provide stiffness to the tab 160 such that when the tab 160 receives a force, the force is primarily transferred through the ribs 170 to the collar 142 of the retention ring 140 without substantially deforming the tab 160 and thus enhancing the ability of the retention ring 140 to focus the deformation of the retention ring 140 at a certain location of the collar 142.
  • the ribs 170 may include gussets 173 extending to the lip 166 of the collar 142 to further transfer the force in a desired manner and to increase the force required to initiate undesirable buckling of the tab 160.
  • the ribs 170 may be approximately 0.050 inches in thickness, which may be an optimal thickness for providing adequate strength without unduly increasing component cost or decreasing manufacturing efficiency.
  • FIG. 10 is an illustration showing a side view of the retention ring 140.
  • the collar 142 of the retention ring 140 may include one or more bendable collar portions 172 that are relatively deformable with respect to other portions of the retention ring 140, such as the remainder of the collar 142, the tab 160, etc.
  • the bendable collar portions 172 may have relatively small cross-sectional dimensions with respect to the remainder of the collar 142 such that, when subjected to a force, the collar 142 tends to deform primarily at the bendable collar portions 172.
  • the bendable collar portions 172 may include a cutout 174 located at least in the lip 166 and that is shaped as an arc with a radius of approximately 1 inch. If the cutout 174 is in the shape of an arc, the edges of the bead 150 (shown in FIG. 9) may optionally be approximately tangent to the arc of the cutout 174. These dimensions may be optimal for certain applications by maximizing the flexibility of the collar 142 at the bendable collar portions 172 without interrupting the function(s) of the bead 150. The cutout 174 may reduce the bending moment of inertia during removal of the collar 142 to thereby reduce the load required to remove the retention ring 140.
  • the retention ring 140 may include a prong 176.
  • the prong 176 may be configured to open the frangible seal 128 by piercing the frangible seal 128 (see FIG. 1) with a spike or point 178.
  • the frangible seal 128 may initially be pierced by a spike 122 (shown in FIG. 1) during a drainage procedure.
  • the piercing of the frangible seal 128 may not have a sufficient opening for efficient removal of fluid or solid medical waste from the container 102 after a drainage procedure.
  • a relatively large opening may be advantageous for simplifying the deployment of the solidifier without the use of a funnel, for example.
  • a user e.g., a patient
  • At least the point 178 of the prong 176 may be sized, shaped, and/or otherwise configured to increase the size of the opening in the frangible seal 128 through manipulation of an edge 180 of the prong 176 through the frangible seal 128 by a user.
  • the prong 176 may be relatively rigid when compared to the frangible seal 128.
  • FIG. 1 1 shows the prong 176 when used to increase the opening of a frangible seal at the mouth 104 of the container 102.
  • the drainage system 100 may include a safety clip 182 that fits around the cap 1 14.
  • the safety clip 182 engages with the cap 1 14 such that it is located around the cap 1 14 and between the flange 132 of the spike 122 and the container 102.
  • the safety clip 182 when engaged, may prevent the spike 122 from moving distally and puncturing the frangible seal 128 prematurely.
  • the safety clip 182 may include a groove 184 that is configured (e.g., sized and shaped) to fit around at least a portion of the collar 142 of the retention ring 140.
  • the engagement between the groove 184 and the retention ring 140 may retain the safety clip 182 in place by preventing its motion in the distal and/or proximal direction. Further, when groove 184 is sized and shaped to fit around at least one of the relatively narrow rim portions 172 (which may incorporate a curve, as described above), the size of the groove 184 with respect to the curve of the rim portions 172 may prevent rotation of the safety clip 182.
  • the safety clip 182 may be removed by a user by pulling on a handle 186, and the drainage procedure may be initiated through movement of the spike 122 when the safety clip 182 is removed (e.g., to pierce a frangible seal as described above).
  • the safety clip 182 may have a prong similar or identical to the prong 176 of the retention ring 140 (e.g., as an alternative to including the prong 176 of the retention ring 140).
  • the extension holding the groove 184 (or another extension) may be configured (sized and shaped) such that it can be used to engage the retention ring 140 when the retention ring 140 is being removed, thereby providing a user with a tool to assist in removal of the retention ring 140 from its engaged state.
  • the safety clip 182 may include a visual indicator (e.g., a molded arrow) depicting the direction that a user must pull to remove the safety clip 182 from the cap 1 14, thus providing instructions to a user for initiation of a drainage procedure.
  • a visual indicator e.g., a molded arrow

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Fluid Mechanics (AREA)
  • Physics & Mathematics (AREA)
  • External Artificial Organs (AREA)
  • Surgery (AREA)

Abstract

Selon un aspect général, la présente invention concerne un système de drainage. Le système de drainage peut comprendre un récipient comportant un intérieur et une embouchure, l'embouchure ayant une surface extérieure et une ouverture. Un joint cassable peut recouvrir l'ouverture. Un capuchon peut être fixé sur l'embouchure, et le capuchon peut être en communication fluidique avec une conduite de drainage. Le capuchon peut avoir une surface intérieure pour entrer en prise avec la surface extérieure de l'embouchure. Le système de drainage peut en outre comprendre une bague de retenue avec un collier ayant une surface intérieure conçue pour venir en prise avec une surface extérieure du capuchon, la bague de retenue comprenant une bille pour concentrer au moins partiellement une force de restriction fournie par la bague de retenue sur une zone adjacente de la surface extérieure du capuchon.
PCT/US2018/044582 2017-07-31 2018-07-31 Système de drainage avec bague de retenue WO2019028010A1 (fr)

Priority Applications (2)

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CA3071622A CA3071622A1 (fr) 2017-07-31 2018-07-31 Systeme de drainage avec bague de retenue
EP18756077.6A EP3661572A1 (fr) 2017-07-31 2018-07-31 Système de drainage avec bague de retenue

Applications Claiming Priority (2)

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US15/664,968 US11185617B2 (en) 2017-07-31 2017-07-31 Drainage system with retention ring
US15/664,968 2017-07-31

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WO2019028010A1 true WO2019028010A1 (fr) 2019-02-07

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EP (1) EP3661572A1 (fr)
CN (2) CN109316637B (fr)
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US20220001095A1 (en) * 2018-11-19 2022-01-06 Kci Licensing, Inc. System And Apparatus For Preventing Therapy Unit Contamination

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CN209951863U (zh) 2020-01-17
CA3071622A1 (fr) 2019-02-07
EP3661572A1 (fr) 2020-06-10
US20190030219A1 (en) 2019-01-31
US11185617B2 (en) 2021-11-30
CN109316637A (zh) 2019-02-12
CN109316637B (zh) 2024-02-23
US20220047784A1 (en) 2022-02-17

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